Vitamin D Deficiency (10 ng/mL to 30 ng/mL) Clinical Trial
— D-SAFEOfficial title:
Effects of Vitamin D Supplementation on Fall Risk and Functional Outcomes in Older Adults With Insufficient Vitamin D Levels: A Pilot Study
| Verified date | December 2016 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The role of vitamin D deficiency on increased risk for falls and physical dysfunction is unclear. It is also unclear if taking vitamin D improves physical function and reduces fall risk in older adults. The purpose of this research study is to explore the effects of taking the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical functional outcomes in older adults with low vitamin D levels. The investigators hypothesize that the participants will experience fewer falls and function better physically after taking vitamin D for six months.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | December 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
Inclusion Criteria: - Age = 70 years - Serum 25-hydroxy vitamin D >10 ng/mL and < 30 ng/mL - Having had a fall at least twice in the past six months - Provide informed consent Exclusion Criteria: - Failure to provide informed consent - Self-reported myocardial infarction, cerebrovascular accident, or unstable angina within the past 6 months; New York Heart Association (NYHA) Class 3 or 4 congestive heart failure; aortic stenosis; chronic hepatitis; cirrhosis; kidney disease; solid organ transplantation; major psychiatric disorder; history of kidney stones or history of renal colic; history of nephrotic syndrome; history of primary hyperparathyroidism or renal tubular acidosis; history of hypercalcemia; cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer); - Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia) that would impair ability to participate in the exercise-based intervention - Cognitive impairment (i.e., Mini Mental Status Exam score < 23) or history of significant head injury - Current use of anabolic medications (i.e., growth hormones or testosterone), antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept), anticoagulant therapies (aspirin use is permitted), or antibiotics for HIV or tuberculosis - Dietary supplementation with > 800 IU/day of Vitamin D - Hypercalcemia (calcium > 10.4 mg/dL), hypocalcemia (calcium < 8.6 mg/dL), or renal insufficiency (estimated glomerular filtration rate (GFR) < 50 ml/min) - Serum aspartate (AST) or alanine transaminase (ATL) >3 times upper limit normal (UPN) - High amounts of physical activity (i.e. running or bicycling) > 120 min/week - Excessive alcohol use ( >14 drinks per wk ) - History of drug or alcohol abuse (i.e., more than 5 drinks/day for males or more than 4 drinks/day for females) - Planning to leave the area in the next year - Resting heart rate > 120 bpm - Systolic blood pressure > 180 mmHg - Diastolic blood pressure > 100 mmHg - Vision or hearing impairment - Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Institute on Aging; University of Florida | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Falls | Assess the change in number of falls participants have after taking vitamin D for six months. | Change in 6 months | No |
| Secondary | Six Minute Walk Test | Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Short Physical Performance Battery (SPPB) | Assess the change in functional performance on the SPPB after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Grip Strength | Assess the change in grip strength after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Weight | Assess the change in weight after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Waist Circumference | Assess the change in waist circumference after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Perceived Level of Functioning as Measured by the Activity Measure for Post-Acute Care (AM-PAC) | Assess the change in perceived level of functioning as measured by the Activity Measure for Post-Acute Care (AM-PAC) after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Medical Outcomes Study Short-Form Health Survey (SF-36) | Assess the change in health-related quality of life after taking vitamin D for six months. | Change in 6 Months | No |
| Secondary | Microbiome in the Human Colon | Assess the change in microbiome in the human colon after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria. | Change in 6 Months | No |
| Secondary | Microbiome in the Human Mouth | Assess the change in microbiome in the human mouth after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria. | Change in 6 Months | No |